MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	DYNCPDS14
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos in line suction ballard cracked at elbow.Patient care not compromised as ballard was replaced.

• Brand Name: MEDLINE
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 24199447
• Report Number: 24199447
• Device Sequence Number: 5507916
• Product Code: BSY
• UDI-Device Identifier: 10888277703384
• UDI-Public: (01)10888277703384
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025
• Report Date (Section F): 12/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNCPDS14
• Device Catalogue Number: DYNCPDS14
• Device Lot Number: 06925080011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Date Report Sent to FDA: 12/22/2025